1. Field of the Invention
The present invention pertains to the field of topical ointments or creams that may be used to sooth pain, swelling, and itching that is associated with anorectal inflammation caused by hemorrhoids and the like. More specifically, the topical ointment contains a vasoconstrictor in combination with a plurality of antibacterial agents.
2. Statement of the Problem
Discomfort due to anorectal inflammation includes pain and itching in tissues proximate the rectum. Anorectal inflammation is most often found in irritated hemorrhoidal tissues, i.e., hemorrhoids, which are varicose dilations of veins in the superior or inferior hemorrhoidal plexus. The dilation results from a persistent increase in venous pressure. Inflammation of anorectal tissues is a complicating factor that enhances the severity of hemorrhoids. The patient often suffers from chronic pain and itching. The inflamed tissue becomes sensitized to the application of medicines intended to treat the problem, and this sensitization can actually cause the medicines to worsen the problem that they are intended to treat. Over time, surgery may be required to remove hemorrhoidal tissues; however, even surgery sometimes does not eliminate the continuing tendency of these tissues to become inflamed. In fact, surgery is only a temporary solution to the problem in most instances. Thus, the cycle of inflammation, discomfort, and sensitization repeats itself even after surgery.
Surgical ligation of hemorrhoids is complicated by the risk of infection, and exotic procedures have been developed, e.g., as described in U.S. Pat. No. 4,621,635, which teaches rubber band ligation of internal hemorrhoidal tissue, followed by a laser incision around the perimeter of the base of the external hemorrhoid portions. The surface of the external hemorrhoid is then evaporated with a traversing movement of the laser beam. The laser beam is then employed to form a cavity into the core of the hemorrhoid and dimensioned to accommodate the subsequent insertion of a cryogenic probe. The probe freezes the hemorrhoidal tissue from the interior outwardly.
There are many different categories of hemorrhoids or hemorrhoidal conditions, and some of these are medically severe conditions requiring surgery. External hemorrhoids result from a varicose dilation of a vein of the inferior hemorrhoidal plexus situated distal to the pectinate line. External hemorrhoids are typically covered with modified anal skin. Internal hemorrhoids are formed of a varicose dilation of the superior hemorrhoidal plexus originating above the pectinate line and covered by mucous membrane. Mucotaneous hemorrhoids result from a varicose dilation of a vein connecting the superior and inferior hemorrhoidal plexuses with the formation of internal and external hemorrhoids in continuity. Prolapsed hemorrhoids are internal hemorrhoids that have descended below the pectinate line with protrusion outside the anal sphincter. Strangulated hemorrhoids are prolapsed hemorrhoids that are sufficiently sever for the action of the anal sphincter to have occluded the blood supply. Thrombosed hemorrhoids contain clotted blood.
The majority of hemorrhoidal conditions are not so severe as to require surgery. Hemorrhoids and associated discomfort due to anorectal inflammation can be treated through the use of topical ointments. Most recent U.S. patents directed towards hemorrhoids and anorectal inflammation pertain to complicated dispensing apparatus for medicinal preparations. U.S. Pat. No. 4,938,221 relates to a hemorrhoid inflammation reducing device having a hollow flexible housing that is shaped to be inserted into and removed from the anus of the rectum of a person having internal or external hemorrhoids. A coolant is disposed within the housing for shrinking the internal/external hemorrhoids. A closure is provided for sealing the coolant within the housing after the coolant is placed within the housing. U.S. Pat. No. 5,004,636 relaters to a roll-type toilet tissue that is formed in three layers, with one layer having a hemorrhoid-treating medication sandwiched between the two other layers. U.S. Pat. No. 4,906,239 relates to a hemorrhoid-treatment rod that is shaped like a cone in order to dilate the anus. Ointment is forced into the cone for dispensation onto the anus, and the ointment can be massaged into the area to be treating by rotating the rod without being wiped off prematurely.
A widely used topical ointment for the treatment of hemorrhoids is PREPARATION H.RTM. (a trademark of Whitehall-Robbins Healthcare located in Madison, N. J.). PREPARATION HO contains active ingredients including 71.9% petrolatum, 14% mineral oil, 3% shark liver oil, and 0.25% phenylephrine HCl. Other ingredients include beeswax, benzoic acid, BHA, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, parrafin, propylparaben, thyme oil, tocopherol, and water. The phenylephrine HCI is a vasoconstrictor that is used to shrink the venous dilations which are the underlying cause of hemorrhoids. Many patients have reported that even vasoconstricting products, such as PREPARATION H.RTM., do not provide complete relief from the anorectal inflammation accompanying hemorrhoids.
There remains a true need for a medicament that provides enhanced relief to patients suffering form anorectal inflammation, such as the anorectal inflammation that is often associated with hemorrhoids.